|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | May 23, 2007 | ||||
| Last Updated Date | August 11, 2009 | ||||
| Start Date ICMJE | April 2001 | ||||
| Estimated Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Response [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Response | ||||
| Change History | Complete list of historical versions of study NCT00477880 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Cetuximab in Treating Patients With Ménétrier Disease at High Risk of Developing Stomach Cancer | ||||
| Official Title ICMJE | Treatment of Ménétrier's Disease With EGF Receptor Blockade | ||||
| Brief Summary | RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. PURPOSE: This clinical trial is studying how well cetuximab works in treating patients with Ménétrier disease at high risk of developing stomach cancer. |
||||
| Detailed Description | OBJECTIVES:
OUTLINE: This is a non-randomized study. Patients receive cetuximab IV on days 1, 8, 15, and 22. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients complete a quality of life questionnaire at baseline and during week 4. PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study. |
||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized | ||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Biological: cetuximab | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 10 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
|
||||
| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | |||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00477880 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000546501, VU-VICC-GI-0602, VU-VICC-IRB-000851 | ||||
| Study Sponsor ICMJE | Vanderbilt-Ingram Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | October 2008 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||